Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01846039




Registration number
NCT01846039
Ethics application status
Date submitted
1/05/2013
Date registered
3/05/2013
Date last updated
16/04/2019

Titles & IDs
Public title
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose
Scientific title
A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
Secondary ID [1] 0 0
VOLXC-AP-ND-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asian Nose Enhancement 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Crosslinked hyaluronic acid gel

Experimental: JUVÉDERM VOLUMA® - Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.


Treatment: Devices: Crosslinked hyaluronic acid gel
Up to 3 mL administered by intradermal injection
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a = 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113
Timepoint [1] 0 0
Baseline, Day 113
Primary outcome [2] 0 0
Percentage of Participants With a = 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
Timepoint [2] 0 0
Baseline, Day 113
Secondary outcome [1] 0 0
Percentage of Participants With a = 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician
Timepoint [1] 0 0
Baseline, Days 239 and 421
Secondary outcome [2] 0 0
Percentage of Participants With a = 1 Grade Improvement on the AAIS as Assessed by the Patient
Timepoint [2] 0 0
Baseline, Days 239 and 421
Secondary outcome [3] 0 0
Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)
Timepoint [3] 0 0
Days 113, 239 and 421
Secondary outcome [4] 0 0
Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)
Timepoint [4] 0 0
Days 113, 239 and 421
Secondary outcome [5] 0 0
Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others
Timepoint [5] 0 0
Days 113, 239 and 421

Eligibility
Key inclusion criteria
* Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
* Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* -Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
* prior nasal surgery, including grafts, implants or filler injection to the nose area
* Subjects with a history of sinusitis or rhinitis
* Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
* Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
* Subjects who have previously received aesthetic treatment in the forehead, glabellar, and/or nose area with any dermal filler
* Subjects with a history of any significant adverse events caused by dermal fillers
* Subjects with a history of allergic responses to lidocaine or fillers
* Subjects who are pregnant or breastfeeding or wish to become pregnant during the study
* Subjects of child-bearing age who are not prepared to practice an adequate form of contraception during the course of the study
* Subjects with traumatic scars in the treatment area or a history of active inflammation, infection, cancerous lesion, or an unhealed wound in the treatment area
* Subjects requiring dental or oral surgery, including dental implants, during the study period
* Subjects with a history of bleeding disorders
* Subjects who are smokers
* Subjects using blood thinning products within 10 days of the screening visit
* Subjects with a history of connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma, etc) causing skin scarring
* Subjects with a history of untreated epilepsy or other significant medical conditions
* Subjects with a history of alcoholism or drug abuse of dependence
* Subjects participating or likely to participate in another clinical trial within 30 days of screening or during the 1 year period of the study
* Subjects with any other medical condition, which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/08/2014
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Gold Coast
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Gold Coast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01846039